BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1231243 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07442
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. A DISPLAY SHOWED "CALL YOUR DOCTOR" ICON, WHICH IS A POWER ON RESET CONDITION. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR LEAD: MODEL 3093| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037